The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.

Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.

Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

Novel Food and Novel Food Ingredient Registration

You are here

Overview

Novel foods or Novel Ingredients (new dietary ingredients) are defined as those foods/ingredients that have not had significant consumption to be considered safe and may include, depending on national regulation, all foods that have been obtained using innovative food technologies or that derived from animal, plants, microbes or minerals sources, not yet currently used for human consumption. Before a novel food can be legally marketed, it is required to have a pre-market safety assessment and or authorization or registration or listing (based on country specific regulations).

This applies to any food and food ingredient that hadn’t been used in the market for human consumption to a significant degree before a particular year (each country will have a different year). The food must also be either:

food ingredients with a new or intentionally modified primary molecular structure

micro-organisms, fungi, algae or cell culture

plants or animals

food produced by new production process that significantly changes the product nutritionally or in relation to the food safety risks

minerals or engineered nanomaterials

With a vast global presence and affiliate network, Freyr assists Novel food product manufacturers to register their products in the regulated markets like the EU, Australia and New Zealand, India, Singapore, and the USA.